FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NASOGASTRIC VOICETUBE
K Number: K871632
·
Decision Sep 16, 1987
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
240
Applicant Total
20
Review Days
142
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Basic Information
- Device Name
- NASOGASTRIC VOICETUBE
- K Number
- K871632
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5730
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- American Omni Medical, Inc.
- Date Received
- April 27, 1987
- Decision Date
- September 16, 1987
- Product Code
- BTR
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | FDA class 2 | Anesthesiology |
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Other Clearances by American Omni Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K922781 | FLOW CONROL VALVE | Mar 8, 1993 | Substantially Equivalent |
| K922356 | FLOW CONTROL VALVE, CAT. NO. ACV-38 | Feb 12, 1993 | Substantially Equivalent |
| K900672 | PREBYPASS FILTER, CAT. NO. FPB-5 | Apr 3, 1990 | Substantially Equivalent |
| K884893 | CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25 | Jan 30, 1989 | Substantially Equivalent |
| K884640 | CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700 | Jan 24, 1989 | Substantially Equivalent |
| K873316 | BUBBLE TRAP-FILTER CAT. NO B180F37 | Jul 14, 1988 | Substantially Equivalent |
| K875080 | AIR VENT LINE CAT. NO. AVL-36 | Feb 29, 1988 | Substantially Equivalent |
| K873802 | PRESSURE BARRIER KIT CAT. NO. PBK-3 | Nov 6, 1987 | Substantially Equivalent |
| K873610 | PEDIATRIC BUBBLE TRAP CAT. NO. B-100 | Nov 5, 1987 | Substantially Equivalent |
| K873488 | SILENT GUARD CAT. NO. SG-10 | Oct 7, 1987 | Substantially Equivalent |